Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

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• Hepatitis C, Chronic 1,090

Hepatitis C, Chronic

1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.

This study's enrollment of 10,228 is above the median of 250 across 247 observational studies indexed under Hepatitis C, Chronic.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.

Study population

Groups and cohorts

• Chronic Hepatitis C

  Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study.

  Drug: Pegylated interferon alfa-2a · Drug: Ribavirin

Interventions

• DrugPegylated interferon alfa-2a

  Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).

  Also known as: Pegasys®

• DrugRibavirin

  Ribavirin administered according to corresponding summary of product characteristics (SmPC).

  Also known as: Copegus®

Primary outcomes

1. Percentage of Participants With Rapid Virologic Response (RVR)

   RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.

   Time frame: At Week 4

2. Percentage of Participants With Early Virologic Response (EVR)

   EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.

   Time frame: At Week 12

3. Percentage of Participants With End of Treatment (EOT) Response

   EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.

   Time frame: Up to Week 72

4. Percentage of Participants With Sustained Virologic Response (SVR)

   SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.

   Time frame: Up to Week 96

5. Percentage of Participants With Serious Adverse Drug Reactions (SADR)

   Time frame: Up to Week 96

Secondary outcomes

1. Percentage Cumulative Dose of Peginterferon Alfa-2a Received

   Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.

   Time frame: Up to Week 96

2. Percentage Cumulative Dose of Ribavirin Received

   Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.

   Time frame: Up to Week 96

3. Duration of Peginterferon Alfa-2a Therapy

   Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.

   Time frame: Up to Week 72

4. Percentage of Participants With the Most Frequent Concomitant Medications

   Most frequent concomitant medications were defined as those, which were observed in \>1 % of participants.

   Time frame: At Baseline (Day 1)

Baseline characteristics

Publications

• Niederau C, Mauss S, Schober A, Stoehr A, Zimmermann T, Waizmann M, Moog G, Pape S, Weber B, Isernhagen K, Sandow P, Bokemeyer B, Alshuth U, Steffens H, Huppe D. Predictive factors for sustained virological response after treatment with pegylated interferon alpha-2a and ribavirin in patients infected with HCV genotypes 2 and 3. PLoS One. 2014 Sep 19;9(9):e107592. doi: 10.1371/journal.pone.0107592. eCollection 2014. PubMed 25238535 ↗